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NCCN Clinical Practice Guidelines in Oncology™
Uterine
Neoplasms
V.1.2010
www.nccn.org
Guidelines Index
Uterine Neoplasms TOC
Staging, Discussion, References
Practice Guidelines
in Oncology – v.1.2010NCCN
®
Version 1.2010, 10/05/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
NCCN Uterine Neoplasms Panel Members
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Gynecologic oncology
† Medical oncology
‡ Hematology
§ Radiotherapy/Radiation oncology
Pathology
* Writing committee memberContinue
NCCN Guidelines Panel Disclosures
Uterine Neoplasms
*
*
*
Benjamin E. Greer, MD/Co-Chair
Fred Hutchinson Cancer Research
Center/Seattle Cancer Care Alliance
Wui-Jin Koh, MD/Co-Chair
Fred Hutchinson Cancer Research
Center/Seattle Cancer Care Alliance
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†
†
Nadeem R. Abu-Rustum, MD
Memorial Sloan-Kettering Cancer Center
Sachin M. Apte, MD, MS
H. Lee Moffitt Cancer Center
& Research Institute
Michael A. Bookman, MD
Fox Chase Cancer Center
Robert E. Bristow, MD
The Sidney Kimmel Comprehensive
Cancer Center at Johns Hopkins
Susana M. Campos, MD, MPh, MS
Dana-Farber/Brigham and Women’s
Cancer Center
John Chan, MD
UCSF Helen Diller Family
Comprehensive Cancer Center
Kathleen R. Cho, MD
University of Michigan
Comprehensive Cancer Center
Larry Copeland, MD
The Ohio State University Comprehensive
Cancer Center - James Cancer Hospital
and Solove Research Institute
Marta Ann Crispens, MD
Vanderbilt-Ingram Cancer Center
Nefertiti duPont, MD, MPH
Roswell Park Cancer Institute
Patricia J. Eifel, MD
The University of Texas
M. D. Anderson Cancer Center
Warner K. Huh, MD
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§
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University of Alabama at Birmingham
Comprehensive Cancer Center
Daniel S. Kapp, MD, PhD
Stanford Comprehensive Cancer Center
John R. Lurain, III, MD
Robert H. Lurie Comprehensive Cancer
Center of Northwestern University
Mark A. Morgan, MD
Fox Chase Cancer Center
Robert J. Morgan, Jr., MD
City of Hope Comprehensive
Cancer Center
Nelson Teng, MD, PhD
Stanford Comprehensive Cancer Center
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† ‡
§
Steven W. Remmenga, MD
UNMC Eppley Cancer Center at
The Nebraska Medical Center
R. Kevin Reynolds, MD
University of Michigan
Comprehensive Cancer Center
Angeles Alvarez Secord, MD
William Small, Jr., MD
Robert H. Lurie Comprehensive Cancer
Center of Northwestern University
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Duke Comprehensive Cancer Center
Guidelines Index
Uterine Neoplasms TOC
Staging, Discussion, References
Practice Guidelines
in Oncology – v.1.2010NCCN
®
Version 1.2010, 10/05/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
This manuscript is being
updated to correspond
with the newly updated
algorithm.
These guidelines are a statement of evidence and consensus of the authors regarding their views of currently accepted approaches to treatment.
Any clinician seeking to apply or consult these guidelines is expected to use independent medical judgment in the context of individual clinical
circumstances to determine any patient's care or treatment. The National Comprehensive Cancer Network makes no representations nor warranties
of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. These
guidelines are copyrighted by National Comprehensive Cancer Network. All rights reserved. These guidelines and the illustrations herein may not
be reproduced in any form without the express written permission of NCCN. ©2009.
Table of Contents
Uterine Neoplasms
Uterine Sarcoma
Endometrial Carcinoma
NCCN Uterine Neoplasms Panel Members
S
Uterine Neoplasms (UN-1)
Disease limited to the uterus (ENDO-1)
Suspected or gross cervical involvement (ENDO-2)
Suspected extrauterine disease (ENDO-3)
Surveillance (ENDO-9)
Recurrence (ENDO-9)
Papillary serous, Clear cell carcinoma, Carcinosarcoma (ENDO-11)
Hysterectomy (ENDO-A)
Systemic Therapy for Recurrent, Metastatic or High-risk Disease (ENDO-B)
Disease limited to the uterus (UTSARC-1)
Known or suspected extrauterine disease (UTSARC-1)
Low-grade Endometrial stromal sarcoma (ESS) (UTSARC-2)
High-grade undifferentiated sarcoma (HGUD)
and Leiomyosarcoma (UTSARC-3)
ummary of Guidelines Updates
Surveillance (UTSARC-4)
Recurrence (UTSARC-4)
Systemic Therapy for Uterine Sarcoma (UTSARC-A)
Uterine Sarcoma Classification (UTSARC-B)
Principles of Radiation Therapy (UN-A)
Guidelines Index
Print the Uterine Cancers Guideline
For help using these
documents, please click here
Staging
Discussion
References
Clinical Trials:
Categories of Evidence and
Consensus:
NCCN
All recommendations
are Category 2A unless otherwise
specified.
See
The
believes that the best management
for any cancer patient is in a clinical
trial. Participation in clinical trials is
especially encouraged.
NCCN
To find clinical trials online at NCCN
member institutions, click here:
nccn.org/clinical_trials/physician.html
NCCN Categories of Evidence
and Consensus
Uterine Neoplasms
Guidelines Index
Uterine Neoplasms TOC
Staging, Discussion, References
Practice Guidelines
in Oncology – v.1.2010NCCN
®
Version 1.2010, 10/05/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
Summary of changes in the 1.2010 version of the Uterine Neoplasms Guidelines from the 2.2009 version include:
Summary of the Guidelines updates
UPDATES
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Endometrial Carcinoma
Age
:
Footnote “g”: Potential adverse risk factors include the following: > 60 y...,” changed to “Potential adverse risk factors include the
following: ...”
�
( )ENDO-4
( )
( )
ENDO-B
UTSARC-A
Systemic Therapy for Recurrent, Metastatic or High-Risk Disease
Chemotherapy Regimens: “Ixabepilone may be used as a single agent for second line treatment of patients (category 2B)” was added.
Chemotherapy Regimens:
First bullet: After “doxorubicin” the following phrase was removed “(most active single agent for LMS)”.
Third bullet: The panel clarified all of the single agent options as category 2B.
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Uterine Sarcoma:
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Uterine Neoplasms
Guidelines Index
Uterine Neoplasms TOC
Staging, Discussion, References
Practice Guidelines
in Oncology – v.1.2010NCCN
®
Version 1.2010, 10/05/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
UN-1
INITIAL
EVALUATION
INITIAL CLINICAL
FINDINGS
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H&P
CBC, platelets
Endometrial biopsy
Chest x-ray
Current cervical
cytology consistent
with
LFT/renal function
tests/chemistry
profile
Consider genetic
counseling for
patients with a
significant family
history
Optional:
NCCN Cervical
Screening Guidelines
Pathology
review
Disease limited
to uterus
Suspected or gross
cervical involvement
Papillary
serous or clear
cell carcinoma
Suspected
extrauterine disease
See Treatment for
Papillary Serous or
Clear Cell Carcinomas
of the Endometrium
or Carcinosarcoma
(ENDO-11)
See Primary Treatment
(ENDO-1)
See Primary Treatment
(ENDO-2)
See Primary Treatment
(ENDO-3)
Pure
endometrioid
Epithelial
carcinoma
Stromal/mesenchymal tumors
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Low-grade endometrial
stromal sarcoma (ESS)
High-grade undifferentiated
sarcoma (HGUD)
Leiomyosarcoma (LMS)
Carcinosarcomaa,b
a
b
Staged aggressively, should be treated as a high-grade endometrial cancer.
Also known as malignant mixed mesodermal tumor or and including those with either homologous or heterologous stromal elements.malignant mixed Müllerian tumor
All staging in guideline is based on FIGO staging. (See ST-1)
Disease limited
to uterus
Known or suspected
extrauterine disease
See Primary Treatment
(UTSARC-1)
Uterine Neoplasms
Guidelines Index
Uterine Neoplasms TOC
Staging, Discussion, References
Practice Guidelines
in Oncology – v.1.2010NCCN
®
Version 1.2010, 10/05/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
ENDO-1
INITIAL CLINICAL
FINDINGS
Disease limited
to the uterus
(endometrioid
histologies)a
Medically
inoperable
Operable
PRIMARY TREATMENT
Tumor-directed RTb
a for clarification of uterine neoplasms.
b
d
c
American College of Obstetricians and Gynecologists practice bulletin, clinical management guidelines for obstetrician-gynecologists, number 65, August 2005:
management of endometrial cancer. Obstet Gynecol 2005 Aug;106:413-425.
See (UN-1
See Hysterectomy (ENDO-A)
)
.
See Principles of Radiation Therapy (UN-A).
See Surveillance
(ENDO-9)
Total hysterectomy and
bilateral salpingo-
oophorectomy (TH/BSO)c
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Cytology
Lymph node dissection
(not random sampling)d
Pelvic lymphadenectomy
Para-aortic
lymphadenectomy
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Adjuvant Treatment for
completely surgically staged:
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Stage I (See ENDO-4)
Stage II (See ENDO-5)
Stage IIIA (See ENDO-6)
Stage IIIB-IV (See ENDO-7)
See (ENDO-8)
Incompletely
surgically
staged
Endometrial Carcinoma
Guidelines Index
Uterine Neoplasms TOC
Staging, Discussion, References
Practice Guidelines
in Oncology – v.1.2010NCCN
®
Version 1.2010, 10/05/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
ENDO-2
Suspected or
gross cervical
involvement
(endometrioid
histologies)a
Negative
result
ADDITIONAL WORKUP PRIMARY TREATMENT
Consider
cervical
biopsy or
MRI
Positive
result or
gross
involvement
e
Operable
Radical hysterectomy and
bilateral salpingo-
oophorectomy (RH/BSO)
or
RT: 75-80 Gy to point A
(category 2B)
c
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Cytology
Lymph node dissection
(not random sampling)d
Pelvic lymphadenectomy
Para-aortic
lymphadenectomy
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f
Inoperable Tumor-directed RTb
TH/BSO
Para-aortic
lymph node
dissection
c
See
Surveillance
(ENDO-9)
INITIAL
CLINICAL
FINDINGS
TH/BSO
Cytology
Lymph node dissection
(not random sampling)d
Pelvic lymphadenectomy
Para-aortic
c
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lymphadenectomy
Adjuvant treatment for
completely surgically
staged:
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Stage I (See ENDO-4)
Stage II (See ENDO-5)
Stage IIIA (See ENDO-6)
Stage IIIB-IV (See ENDO-7)
Clear demonstration of cervical stromal involvement.
a for clarification of uterine neoplasms.
Based on summation of conventional external-beam fractionation and low-dose-rate brachytherapy equivalent.
b
c
d
f
American College of Obstetricians and Gynecologists practice bulletin, clinical management guidelines for obstetrician-gynecologists, number 65, August
2005: management of endometrial cancer. Obstet Gynecol 2005 Aug;106:413-425.
e
See (UN-1)
See Hysterectomy (ENDO-A)
See Principles of Radiation Therapy (UN-A).
.
See
(ENDO-8)
Incompletely
surgically
staged
Endometrial Carcinoma
Guidelines Index
Uterine Neoplasms TOC
Staging, Discussion, References
Practice Guidelines
in Oncology – v.1.2010NCCN
®
Version 1.2010, 10/05/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Suspected
extrauterine
disease
(endometrioid
histologies)a
None
Intra-abdominal:
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Ascites
Omentum
Nodal
Ovarian
Peritoneal
Extrauterine pelvis:
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Vaginal
Bladder
Bowel/rectum
Parametrial
Extra-abdominal/liver
See Primary Treatment
(disease limited to uterus)
(ENDO-1)
RT ± surgery + brachytherapy
± chemotherapy
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CA-125
MRI/CT, as
clinically
indicated
TH/BSO + cytology
± maximal debulking
± pelvic and para-aortic
lymph node dissection
c
d
Consider palliative TH/BSO
± RT ± hormonal therapy
± chemotherapy
Adjuvant treatment for
completely surgically staged:
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Stage IIIA (See ENDO-6)
Stage IIIB-IV (See ENDO-7)
See Surveillance
(ENDO-9)
ADDITIONAL
WORKUP
PRIMARY TREATMENTINITIAL
CLINICAL
FINDINGS
a for clarification of uterine neoplasms.
c
dAmerican College of Obstetricians and Gynecologists practice bulletin, clinical management guidelines for obstetrician-gynecologists,
number 65, August 2005: management of endometrial cancer. Obstet Gynecol 2005 Aug;106:413-425.
See (UN-1)
See Hysterectomy (ENDO-A).
ENDO-3
Endometrial Carcinoma
Guidelines Index
Uterine Neoplasms TOC
Staging, Discussion, References
Practice Guidelines
in Oncology – v.1.2010NCCN
®
Version 1.2010, 10/05/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
ENDO-4
CLINICAL FINDINGS
G1
Stage IA
G2
Stage IB
( 50%)
myometrial
invasion
�
Stage IC
(> 50%)
myometrial
invasion
Adjuvant
treatment for
completely
surgically
staged: Stage I
G3i,j
b
g
i
j
Potential adverse risk factors include the following: Age, positive lymphovascular invasion, tumor size, lower uterine (cervical/glandular) involvement.
hAdjuvant therapy determinations are made on the basis of pathologic findings.
The role of adjuvant chemotherapy in invasive high-grade uterine confined disease is the subject of current studies. (Creutzberg, CL Clinical Trial: Chemotherapy and
Radiation Therapy Compared With Radiation Therapy Alone in Treating Patients With High-Risk Stage I, Stage II, or Stage III Endometrial Cancer; Clinical trial
summary from the National Cancer Institute's PDQ® database. Study ID Numbers: CDR0000521447; CKTO-2006-04; ISRCTN14387080; CKTO-PORTEC-3; EU-
20664--- . Hogberg T, Rosenberg P, Kristensen G, et al. A
randomized phase-III study on adjuvant treatment with radiation (RT) ± chemotherapy (CT) in early-stage high-risk endometrial cancer (NSGO-EC-9501/EORTC
55991) [abstract]. J Clin Oncol 2007;25:5503).
See Principles of Radiation Therapy (UN-A)
http://clinicaltrials.gov/ct/show/NCT00411138;jsessionid=2309E60C1051E921B4E2614F2BE708A4?order=9
.
See Systemic Therapy for Recurrent, Metastatic, or High-Risk Disease (ENDO-B).
See
Surveillance
(ENDO-9)
ADVERSE RISK
FACTORSg
Adverse
risk factors
present
Adverse risk
factors not
present
Adverse
risk factors
present
Adverse risk
factors not
present
Adverse
risk factors
present
Adverse risk
factors not
present
HISTOLOGIC GRADE/ADJUVANT TREATMENTb,h,i,j
Observe
or
Vaginal brachytherapy
Observe
or
Vaginal brachytherapy
Observe
or Vaginal brachytherapy
and/or Pelvic RT
Observe
or Vaginal brachytherapy
and/or Pelvic RT
Observe or Pelvic RT
and/or Vaginal brachytherapy
± chemotherapy (category 2B
for chemotherapy)
Observe
Observe
or
Vaginal brachytherapy
Observe
or
Vaginal brachytherapy
Observe
Observe
or Vaginal brachytherapy
and/or pelvic RT
(category 2B for all options)
Observe
or Vaginal brachytherapy
and/or Pelvic RT
Observe
Observe
or
Vaginal brachytherapy
Observe
Observe
Observe
or
Vaginal brachytherapy
Observe
aginal brachytherapy
and/or Pelvic RT
or V
Observe
or Vaginal brachytherapy
and/or Pelvic RT
Endometrial Carcinoma
Guidelines Index
Uterine Neoplasms TOC
Staging, Discussion, References
Practice Guidelines
in Oncology – v.1.2010NCCN
®
Version 1.2010, 10/05/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
ENDO-5
Stage IIA
Stage IIB
Pelvic RT
+ vaginal brachytherapy
Pelvic RT
+ vaginal brachytherapy
± chemotherapy
(category 2B for chemotherapy)
Pelvic RT
+ vaginal brachytherapy
b
h
i
j
k
Adjuvant therapy determinations are made on the basis of pathologic findings.
Observation or vaginal brachytherapy is an option for patients with Stage II disease who are post primary radical hysterectomy, with negative surgical margins and
no evidence of extrauterine disease.
The role of adjuvant chemotherapy in invasive high-grade uterine confined disease is the subject of current studies. (Creutzberg, CL Clinical Trial: Chemotherapy
and Radiation Therapy Compared With Radiation Therapy Alone in Treating Patients With High-Risk Stage I, Stage II, or Stage III Endometrial Cancer; Clinical trial
summary from the National Cancer Institute's PDQ® database. Study ID Numbers: CDR0000521447; CKTO-2006-04; ISRCTN14387080; CKTO-PORTEC-3; EU-
20664--- . Hogberg T, Rosenberg P, Kristensen G, et
al. A randomized phase-III study on adjuvant treatment with radiation (RT) ± chemotherapy (CT) in early-stage high-risk endometrial cancer (NSGO-EC-
9501/EORTC 55991) [abstract]. J Clin Oncol 2007;25: 5503).
See Principles of Radiation Therapy (UN-A)
http://clinicaltrials.gov/ct/show/NCT00411138;jsessionid=2309E60C1051E921B4E2614F2BE708A4?order=9
.
See Systemic Therapy for Recurrent, Metastatic, or High-Risk Disease (ENDO-B).
CLINICAL FINDINGS
Adjuvant
treatment for
completely
surgically
staged: Stage IIk
G1 G2 G3i,j
HISTOLOGIC GRADE/ADJUVANT TREATMENTb,h,i,j
See
Surveillance
(ENDO-9)
Optional vaginal brachytherapy for all patients;
for recommendations based on findings in the uterine fundus
(See ENDO-4)
Endometrial Carcinoma
Guidelines Index
Uterine Neoplasms TOC
Staging, Discussion, References
Practice Guidelines
in Oncology – v.1.2010NCCN
®
Version 1.2010, 10/05/09 © 2009 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.
Note: All recommendations are category 2A unless otherwise indicated.
Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.
Adjuvant treatment
for completely
surgically staged:
Stage IIIA
All other IIIA
ObservelObservel
Chemotherapy ± RT
or
Tumor-dir
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